MANDATORY VACCINATION:
WHY WE STILL GOT TO GET FOLKS TO TAKE THEIR
SHOTS

Ben Balding

Class of 2006

April 27, 2006

This paper is submitted in satisfaction of the
Food and Drug Law course paper and the Harvard Law School 3L
Written Work Requirement

ABSTRACT

Vaccination is widely considered one of the
greatest medical achievements of modern civilization. Childhood
diseases that were commonplace less than a generation ago are now
increasingly rare because of vaccines. In order to be effective at
eliminating communicable diseases, vaccines must be administered to
sufficient levels of persons in the community. Because of this,
public health officials have mandated vaccination for certain
diseases as a condition to school attendance. The overwhelming
effectiveness of vaccination programs may lead individuals to
ignore the benefits of vaccination and focus more on the risk of
side effects. Moreover, some have criticized the coercive nature of
these programs. These objections may lead to an unacceptably high
number of exemptions, which can compromise vaccination programs and
leave the population susceptible to outbreaks.

This paper explores vaccination programs with an
eye toward greater public safety without ignoring the reality of a
small but committed group of vaccine critics. The paper begins with
a discussion of the historical development of mandatory vaccination
policies and the issues posed by exemptions. It then addresses some
of these issues in the context of vaccine safety. It also seeks
solution by framing the discussion in economic terms. It concludes
by recommending stricter enforcement of mandatory requirements for
most vaccines and greater dissemination of information on the
continued importance of vaccination.

TABLE OF CONTENTS

INTRODUCTION

Vaccination is widely considered one of the
greatest medical achievements of modern civilization. Childhood
diseases that were commonplace less than a generation ago are now
increasingly rare because of vaccines. The smallpox vaccine has
eradicated a disease that was responsible for centuries of
outbreaks and had a 30% fatality rate.[1] Physical handicaps resulting from polio can still
be observed on some of those who were children before Jonas Salk
developed a vaccine in 1955. Formerly common childhood diseases are
now rarely observed. Even ear infections may soon be prevented by
vaccination.[2] The widespread success of vaccinations has led one
medical report to comment that “[n]ext to clean water, no
single intervention has had so profound an effect on reducing
mortality from childhood diseases as has the widespread
introduction of vaccines.”[3]

The story of modern vaccination begins with Edward
Jenner’s development of the vaccine for smallpox, one of the
most feared diseases in recent history. At first, vaccination was
optional and not everyone chose to vaccinate.[4] In time, states would allow municipalities to
mandate vaccination in time of outbreak in order to protect the
public from epidemics.[5] A further step was taken when states imposed
smallpox vaccination as a prerequisite for attending public
schools.[6] These requirements were amended in time as new
vaccines were developed.[7] At some point actual outbreaks and epidemics ceased
to be the trigger for mandatory vaccination, and prevention became
the overriding justification.[8] Most states today require vaccination for a
multitude of childhood diseases, including measles, diphtheria,
pertussis, polio, and now even chickenpox.[9]

Because of the success and the mandatory nature of
vaccination, most people would probably not consider vaccination an
optional method of medical treatment. For most parents, the
“decision” to vaccinate is equivalent to the
“decision” to feed one’s child.[10] Typically, a doctor informs parents of the school
vaccination schedule and the parents consent to having their child
vaccinated. Since the vaccination schedule usually corresponds to
the scheduled doctor visits for infants, full compliance with
mandatory vaccination schedules is typically not a problem and can
usually be substantially accomplished by age two.[11]

For some parents, however, vaccination is no
routine matter.[12] From the time of Jenner’s smallpox vaccine,
vaccination has had its critics.[13] In the two centuries since that time, many
different types of objections have been raised. Some have
questioned the scientific qualifications of mass
immunization.[14] Others have focused on the personal liberty
interests at stake and have objected to the paternalistic nature of
government imposition of what is viewed as a personal medical
choice.[15] Still others have opposed vaccination for personal
or religious reasons.[16]

Today, some parents raise similar objections. The
idea that a potentially harmful substance is being placed directly
into the bloodstream raises a red flag for some. Additionally, the
decline of many diseases for which vaccination is still mandated
may make some parents skeptical of the continued wisdom of
subjecting a child to a vaccine, even if the vaccine is considered
extremely safe. This skepticism grows when some point to the
correlation between vaccinations and conditions such as SIDS and
autism. Whether or not such a correlation is scientifically
significant, many parents simply wonder if it is wise to vaccinate
against a disease unlikely to afflict their child if any chance
exists that the vaccine will cause autism, SIDS, or any other side
effect.[17]

Since the efficacy of a particular vaccine
corresponds directly with the percentage of a given population that
has been vaccinated, proponents of mandatory vaccination have
sought to convince those with reservations about vaccines that
vaccination is the right choice. The Center for Disease Control has
attempted to allay possible reservations parents may have with
vaccinations by rebutting some of the commonly held fears about
vaccines.[18] The CDC has pointed out, for example, that most
adverse effects from vaccines are “minor and temporary, such
as a sore arm or mild fever.”[19] Because vaccination often involves the
introduction of a harmful live (although seriously weakened)
organism into the patient, vaccination can never be 100% safe.
Serious side effects usually occur only between one per thousands
to one per millions of doses, while some serious reactions and
death occur so rarely that accurate risk assessment is
difficult.[20] The CDC has also responded to many of the other
concerns raised about the need for vaccination, and the FDA
continually works to ensure vaccine safety and efficacy, but many
still harbor reservations toward vaccination.

This paper will endeavor to discuss some of the
most common objections to vaccination programs in general while
trying to shed light on the veracity and tenability of these
objections. Part I will discuss the nature of mandatory vaccination
programs in this country; both scientific and historical issues
will play a key part in this discussion. Part II will describe the
role of the FDA and other governmental bodies in the overall
vaccination picture. Part III will attempt to utilize multiple
analytical tools in search of possible solutions to the dangers
posed by those who may attempt to opt out of vaccination programs.
It will first examine vaccination through the lens of an old
television show episode. It will then adopt an economic analytical
framework to discuss the balance between individual and general
welfare in the context of vaccination. Part IV will conclude with
some observations on how the goal of greater public health might be
achieved without completely neglecting the concerns of many in the
community regarding the prudence of using a medical technique that
by definition relies on a degree of coercion.

I. MANDATORY VACCINATION

Historical Background

Jenner’s smallpox vaccine led to the research
and development of vaccines for other widespread and epidemic
diseases. The twentieth century saw the development of vaccines for
such diseases as polio, diphtheria, tetanus, pertussis, measles,
and others.[21] As with the smallpox vaccine, many of these
vaccines soon found their way into vaccination programs mandated by
the government, albeit through a somewhat different pathway.

Mandatory smallpox vaccination programs typically
arose through state police power legislation authorizing
municipalities to deal with outbreaks.[22] Typically, when a local municipality decided that
the threat of outbreak was sufficient to exercise this authority it
would require vaccination of everyone in the community (with a
possible exception for individuals who could demonstrate uncommonly
high health risks from receiving the vaccine, although this
exception sometimes applied only to children) and fine and/or
quarantine those who refused to be vaccinated.[23] When other diseases became preventable by
vaccination, outbreak ceased to be the trigger for mandatory
vaccination. Rather, because of their cost-efficiency and their
ability to reduce and ultimately eliminate disease, vaccination
programs became an important part of general public health
policy.[24]

Most of the time, vaccination programs are
accomplished through the dual efforts of national entities (which
tend to develop and recommend vaccines) and state legislatures and
local boards of health (which usually implement these recommended
vaccines through vaccination programs).[25] It is not entirely accurate to refer to this as
“mandatory vaccination,” as typically individual states
will not criminally punish parents for not vaccinating their
children or forcefully subject individuals to vaccination.[26] Instead, states typically condition school
enrollment on proof of vaccination.[27] Though it may be a high price to pay, home
schooling is usually an available means parents have if they wish
to bypass these vaccination requirements. Moreover, most states
grant exemptions to vaccination requirements for religious reasons
and some even grant exemptions for philosophical reasons (in
addition, every state exempts from school vaccination requirements
individuals who cannot be vaccinated for medical reasons).[28]

The connection between school enrollment and
vaccination programs may now seem obvious. Public health officials,
faced with a means of protecting the general population from the
harmful disease smallpox, realized that mass vaccination could lead
to a sufficient level of immunity to eliminate the risk of
outbreak, even for those in the community unable to vaccinate
(because of medical reasons, for instance).[29] Because of the concept of herd immunity, public
health officials considering the proper utilization of vaccines
were dealing with a medical procedure quite out of the ordinary.
Since vaccination itself does not typically provide 100% immunity
to a disease, vaccinated individuals can still contract the
disease.[30] Yet because of herd immunity, if a sufficient
level of vaccination within a population is attained, the entire
population will no longer be susceptible to the disease. In this
way, vaccination came to be viewed not only as a personal medical
choice but also as a step taken to improve the overall health of
the population.

With the rise of public schooling in the mid- to
late-nineteenth century, cities decided to condition public school
attendance on smallpox vaccination.[31] By the latter part of the century, many states had
adopted this practice.[32] Such a policy makes sense when one considers the
increased risk of infectious disease in public areas like cities in
general and schools in particular. By mandating vaccination for
school attendance, of course, the state would eventually have
ensured the vaccination of the entire population by the time the
initially vaccinated generation became the oldest living one.

These vaccination schemes have faced challenges,
both legal and social, throughout their existence.[33] The reasons for such challenges have ranged from
personal liberty interests to doubts about the efficacy of
vaccines.[34] State courts in the nineteenth century typically
upheld both the enactment of mandatory vaccination programs and the
delegation of power to local authorities.[35] More importantly for the future of mandatory
vaccination policy, two important Supreme Court decisions in the
early part of the twentieth century affirmed the power of state
governments both to mandate vaccination and to delegate a broad
degree of authority to local municipalities and health boards to
carry out particular vaccination programs.

Judicial Approval

In 1905 the Court held in Jacobson v.
Massachusetts[36] that the general police power of states is broad
enough to overcome a Due Process claim brought by an individual who
claimed his personal liberty interests were unconstitutionally
invaded by the mandatory smallpox vaccination program in
question.[37] In an opinion by Justice Harlan, the Court ruled
that the constitutional guarantee of liberty “does not import
an absolute right in each person, to be, at all times and in all
circumstances wholly free from restraint.”[38]

This case still represents the initial
constitutional basis of most mandatory vaccination legislation.
Many states still provide for the governor or a public health
official to mandate vaccination for all in the event of an
outbreak.[39] Individuals who cannot vaccinate for health
reasons or who refuse to vaccinate may be quarantined in order to
protect the population in some states.[40] These laws gained greater relevance following the
terrorist attacks of 9/11 and the increased public concerns
regarding bioterrorism. For the most part, however, mandatory
vaccination laws in the name of outbreak control have given way to
vaccination requirements as a prerequisite for school
attendance.

The issue of school vaccination came before the
Court nearly two decades after Jacobson . In Zucht v.
King[41] , the plaintiff challenged a general grant of
authority from Texas to local boards of health to condition school
entry on proof of vaccination.[42] To differentiate the case from Jacobson ,
the plaintiff noted that the San Antonio ordinances mandated
vaccination even in the absence of evidence of outbreak.[43] The Court, speaking this time through Justice
Brandeis, upheld the validity of the ordinances as well as the
broad grant of authority to local health boards.[44] On the issue of the state’s power to mandate
vaccination, he merely cited Jacobson : “[l]ong before
this suit was instituted, Jacobson v. Massachusetts...had settled
that it is within the police power of a state to provide for
compulsory vaccination.”[45] As for entrusting a broad degree of authority on
local health officials, he noted that Jacobson and other
cases had affirmed that a state may “delegate to a
municipality authority to determine under what conditions health
regulations shall become operative.”[46] This delegation includes the permission to vest
municipal officials with “broad discretion in matters
affecting the application and enforcement of a health
law.”[47] In summary, the Court found that these ordinances
were valid assignments of “that broad discretion required for
the protection of the public health.”[48] The language of the opinion emphasizes the
importance of the public health as the key justification for
mandatory vaccination.

Zucht , along with Jacobson , thus
became the legal foundation for the mandatory vaccination laws of
the twentieth century. Modern school vaccination laws and policies
have grown from early mandatory smallpox vaccination laws:

The early successes of school vaccination laws
against most political, legal, and social challenges helped lay the
foundation for modern immunization statutes. Since the introduction
of smallpox vaccination policies in the mid-to-late 1800s, states
have amended them to include additional diseases as new vaccines
become available.[49]

Though various amendments and additions have been
made to mandatory vaccination laws throughout their history, the
past half century has experienced the true culmination of mandatory
vaccination policy. Public health officials have been able to
institute a scheme for near-universal vaccination:

Many existing school vaccination laws were enacted
in response to the transmission of measles in schools in the 1960s
and 1970s. State legislatures at that time were influenced by the
significantly lower incidence rates of measles among school
children in states that strictly enforced vaccination requirements
and school exclusions in outbreak situations without significant
community opposition. Rather than having health departments require
immunization in emergency conditions, legislatures acted to prevent
disease by mandatory immunization as a condition of enrollment or
attendance in schools or licensed day care facilities.[50]

Moreover, states have not been completely left to
implement the recommended immunization schedule.[51] Though school requirements are still a state
matter, national public health officials are typically able to
enact their recommendations through federally funded immunization
plans.[52] These plans require states to implement and
enforce federally recommended immunization requirements before the
states can receive federal funds.[53] The current recommended vaccination schedule
appears below.

2 months, 4 months, 6 months, 15-18 months, 4-6
years, Td booster at age 12 and every 10 years thereafter

Haemophilus influenzae type b
conjugate

Hib

3

2 months, 4 months, 12-15 months

Inactivated Poliovirus

IPV

4

2 months, 4 months, 6-18 months, 4-6
years

Measles, mumps, and rubella

MMR

2

Two shots at least four weeks apart beginning
at age 12 months

Varicella

Chickenpox

1

Any time after age 12 months if the child has
not had chickenpox

Meningococcal

MCV4

1

11-12 years

Pneumococcal

PCV

4

2 months, 4 months, 6 months, 12 months

Influenza

Influenza

Annual

6 months and annually thereafter for children
with certain risk factors

Hepatitis A

HepA

2

First dose at 12 months, second dose at least 6
months thereafter

Challenges and Concessions

While school vaccination requirements have been
credited with bringing about the control and elimination of many
devastating childhood diseases, critics have continued to voice
concerns and raise legal and political challenges to the entire
process of mandatory vaccination.

Personal Liberty Concerns

One key argument against mandatory school
vaccination has always focused on government intrusion into what is
considered a personal medical choice.[55] Just as the government cannot force a person to
have surgery to repair a torn ligament, for example, the government
should not be able to force parents to vaccinate their children if
the parents believe that vaccination is not the best medical
decision. One prominent critic of mandatory vaccination has stated
her organization’s goal as simply providing parents with
choices: “[w]e believe that health care consumers should have
the right to choose the type of preventive health care that they
want to use – including choosing whether to use one, ten, or
no vaccines.”[56] Other objections along similar bases argue that
mandatory vaccination violates the medical ethic of informed
consent or even that school district control over mandatory
vaccination policies amounts to the unlawful practice of medicine
without a license.[57]

The typical counterargument given by the public
health officials is to point out that one’s decision to
vaccinate, unlike one’s decision whether to undergo surgery,
affects the health of others in the community.[58] To allow parents the right to choose not to
vaccinate is to infringe on the ability of other parents to raise
their children in a society free of certain deadly diseases. From a
legal standpoint, Jacobson still seems to have settled the
issue that at least under some circumstances, the government may
force an individual to receive a vaccination.

Although public health officials have the legal
authority to mandate vaccination for the public health under
Jacobson, they should be very mindful of the personal liberty
concerns just stated. Those with such views often cling to them
vigorously.[59] As certain vaccine-preventable diseases decline,
such concerns become even stronger. For this reason, it is
important for public health officials to support their mandatory
vaccination programs with justifiable arguments rather than simply
citing legal precedent or historical tradition in support of their
exercise of power. Fortunately for public health officials, the
benefits provided by vaccination programs can be utilized to
justify the existence of such programs.

Safety Accountability Concerns

A variation on the consumer choice challenge to
mandatory school vaccination requirements tends to accuse the
public health community of conspiring with or at least willfully
acquiescing to powerful vaccine manufacturers at the expense of
citizens.[60] Mandatory programs, the argument goes, eliminate
any accountability from vaccine manufacturers that the free market
might otherwise provide.[61] Both the safety and efficacy of vaccines fail to
improve because manufacturers do not have to respond to consumer
concerns.[62] Mandatory programs thus prevent better vaccines. A
prominent critic of these programs has stated that if mandatory
vaccination programs are ended, “we will have the ability to
put economic pressure on the drug companies and on the health
agencies to do a better job with vaccine safety and
efficacy.”[63]

The strength of this argument lies in its apparent
lack of hostility toward vaccines per se. Given the historical
success of vaccination in eradicating smallpox and in reducing or
eliminating the risk of other childhood diseases, any critique of
mandatory vaccination programs that focuses on the use of vaccines
generally is likely to be dismissed by those in the field of public
health. By focusing on the economic drawbacks inherent in a
mandatory vaccination program and how those drawbacks can
negatively affect the quality of vaccines, this argument may gain
more traction. Indeed, all sides of this debate claim to desire
both safer and more effective vaccines.

The response to this argument, I would imagine,
would be to emphasize the drawbacks of opening up the
“market” in this case. Because vaccination programs
depend on a sufficient percentage of the community being
vaccinated, complete consumer choice carries with it problems that
might be absent in a standard market. As for vaccine quality, FDA
regulation is in place to ensure a sufficient level of safety and
efficacy to accomplish the goals of vaccination.[64] The pressure faced by vaccine manufacturers to
obtain and maintain FDA approval should provide a check sufficient
to guarantee proper vaccine quality. If not, the answer should be
to raise FDA standards, rather than to jettison the entire
mandatory vaccination process and with it the likelihood of
maintaining a sufficient level of immunity among the
population.

This response might be unacceptable to those
concerned. If the connection between public health officials
entrusted with implementing the mandatory vaccination schedule and
FDA regulators entrusted with ensuring the safety and efficacy of
vaccines is seen as too close, proposing higher FDA standards as a
solution may not allay concerns. The independence and integrity of
FDA is therefore critical in this arena, just as it is in other
areas of public health.

Concern of Unknown Risks

In what may be a combination of the two challenges
previously discussed, many individuals challenge vaccine programs
because of a lack of information about vaccines.[65] Many people, for example, legitimately question
the wisdom of forced vaccination before long-term effects of a
vaccine are studied. One website that purports “to provide a
wide range of news and views on vaccination and vaccination
policy” has summarized this challenge to vaccines simply as
opposing the idea of “a parent, any parent, being forced to
do something that has even a remote chance of harming their
child.”[66] Since long-term (ten or more years down the road)
and low-risk (on the order of one-per-million or less, for example)
side effects may truly be unknown, this concern does present a
challenge for public health officials.[67]

Unfortunately, even the best studies are unable to
fully determine all long-term consequences of vaccination. In
addition, “[t]here is no such thing as a
‘perfect’ vaccine which protects everyone who receives
it AND is entirely safe for everyone.”[68] Therefore, it is true that mandatory vaccination
probably forces some parents to inject their children with a
substance that will cause some unknown harm.

As with the other objections to mandatory
vaccination, however, this objection suffers from a critical flaw.
Mandatory school vaccination requirements are not justified solely
on the benefit they provide to the recipient. Instead, it is the
benefit they provide to the community as a whole by ensuring a
sufficient level of vaccination to prevent outbreak that justifies
their intrusive nature on individual medical
decision-making.[69] For this reason, if public health officials did
not enact the mandatory vaccination program, they would be
forcing on parents a system that had at least a “remote
chance of harming their child.”[70] Because the decision to enact a community-wide
vaccination program must be made at the general level if it is to
be made at all, and because some children will undoubtedly suffer
some health consequences regardless of which policy is chosen,
individuals will always be able to raise this argument against
mandatory vaccination programs.

A better critique of these programs would focus on
whether mandatory vaccination causes more overall harm than
a voluntary system; that is, is it better when viewed at the
general, rather than the individual, level? Ironically, the very
success of vaccination programs in reducing the incidence of
once-prominent diseases has led some to ignore the overall and
continuing benefit of community vaccination (herd
immunity).[71] But for parents to decry the “remote
chance” of harm from vaccination while ignoring the very real
chance of outbreak in an under-vaccinated population is to reframe
the issue entirely.

Other Concerns

Other challenges to vaccination laws have cited
strongly held religious or philosophical positions against
vaccination in general. Such challenges require a different type of
response from public health officials; often the options are
limited to overriding such objections and excluding children of
parents adhering to such positions from public schools (which is
constitutionally permissible under Jacobson and its progeny)
or creating exemptions to vaccination requirements (which is
detrimental to the overall goals of mandatory vaccination if a
sufficient number of exemptors exist). Reactions to such religious
and philosophical concerns vary from state to state, with a general
trend toward greater accommodation of objectors.

Exemptions

In response to these and other challenges to
mandatory vaccination laws, states have enacted various exemptions
to vaccination requirements for school entry. Actual enforcement
varies by state.

Medical

All states provide exemptions for those with
medical risks associated with vaccines.[72] If certain contraindications indicate a likelihood
of harm from a particular vaccine, the exemption will be
allowed.[73] Because such cases are rare and exemptions
relatively easy to enforce, there usually is very little risk of
compromising the efficacy of the overall vaccination program by
granting these exemptions.[74] The ability to grant medical exemptions while
still maintaining sufficient levels of vaccination to provide
community-wide immunity is one of the great accomplishments of the
vaccination system.[75]

Religious

In addition to medical exemptions, almost every
state grants religious exemptions for those with sincere religious
beliefs opposing vaccination.[76] Individual states tend to vary with regard to the
level of religious conviction necessary to obtain a religious
exemption. Such exemptions reflect the sometimes uneasy balance
between mandatory vaccination programs and First Amendment Free
Exercise rights, even though the Supreme Court has validated the
right of states to mandate vaccination without providing for such
exemptions.[77] West Virginia, for example, does not provide
religious exemptions.[78]

Some religious exemption statutes have spurred
challenges on Establishment Clause grounds by those who claim they
favor organized or recognized religions over the sincerely held
religious views of others.[79] These challenges, if successful, would lead to the
invalidation of many religious exemption statutes. Rather than
decrease the number of religious exemptors, however, this may
actually lead to more religious exemptors. The political climate of
our day, along with the experience of a few states already (such as
Arkansas), suggests that legislatures may respond to invalidation
of religious exemption statutes that require adherence to an
organized religion by drafting more general and expansive religious
exemption statutes.[80] By subjugating religion to compulsory vaccination,
courts may actually be helping to bring about a system with even
more religious exemptors, thereby harming the very vaccination
programs to which religious objections had been
subordinated.[81]

Philosophical

The possibility that some parents who strongly
oppose vaccination for other than religious reasons has led to
other means of exempting from mandatory vaccination programs. In
some states, people may avoid vaccination requirements by way of
philosophical exemptions.[82] In California, for example, a parent need only
“submit a letter or affidavit stating that the immunization
is contrary to his or her beliefs” to exempt their child from
vaccination requirements.[83] “Where available, parents are taking
advantage of such exemptions with growing regularity; and in states
offering both exemptions, the number of philosophical exemptions
far exceeds the number of religious and medical
exemptions.”[84]

States without philosophical exemptions, moreover,
are often lax with their enforcement of religious
exemptions.[85] Because of this, parents in these states can
usually submit insincere affidavits purporting to object to
vaccination for religious reasons and local health officials,
unconcerned with delving into the sincerity of such affidavits,
will widely grant exemptions.[86] In most states, therefore, persistent parents can
usually find some way to exempt their children from vaccination
requirements. If all else fails and vaccination is still regarded
as unacceptable to the parent, the option of home schooling may
provide a final avenue of evading these school vaccination
requirements.

Dangers of Widespread Exemptions

The ease with which non-medical exemptions can
typically be obtained has raised concerns among many that the
benefits of widespread immunization are being compromised.[87] Because of the nature of medical exemptions,
unvaccinated persons in a community with only medical exemptions
would be expected to be few and dispersed. Herd immunity can be
attained, and protection is ensured for both the vaccinated
majority and the unvaccinated few.[88] Broadly granted philosophical and religious
exemptions make herd immunity more difficult to attain and increase
the risk to the community. This risk is exacerbated by the fact
that many of those who apply for such exemptions “will
cluster together in one geographic area.”[89] This cluster effect tends to increase the
likelihood of serious outbreaks:

Recent studies have shown that clusters of
exemptors, who are significantly more susceptible to contracting
vaccine preventable illnesses, pose an increased risk of spread of
diseases not only to their unimmunized peers, but also to the
surrounding, largely vaccinated population.[90]

Given that many childhood diseases seem to be in
decline, exemptors may fail to realize the continued value of
vaccination. As the mumps outbreak in Iowa makes clear, however,
vaccination programs take time and are at risk if vaccination rates
fall. Other diseases are still prevalent in other parts of the
world, and outbreaks can still occur in this country due to the
prevalence of international travel. Ever though measles is rarely
observed in the US, for example, the World Health Organization has
reported that nearly 900,000 measles-related deaths occurred in
developing countries in 1999.[91] Until diseases are eradicated globally, it may be
necessary to continue vaccination.

Because many of the aforementioned risks are
frequently underappreciated by those who seek exemptions, some have
suggested a combination of stricter enforcement of exemption
requirements and increased public knowledge of the reasons
underlying childhood vaccination requirements.[92] Knowledge is indeed essential to the resolution of
this problem. The easier it is to obtain an exemption, the less
likely individuals are to understand and appreciate the importance
of widespread participation to the success of a vaccination
program. Greater public appreciation of the need for such
participation (even for diseases that seem to be in retreat), along
with greater information on the safety of vaccines can go a long
way toward increasing public health in this area.[93]

Partial Exemptors – A Modern Phenomenon

The availability of exemptions has led to other
interesting developments in the vaccination debate. Recently, for
example, challenges have been raised against the need for mandatory
chickenpox and hepatitis B vaccines. Diseases such as these, which
are either not greatly feared (chickenpox) or transmitted primarily
through voluntary rather than involuntary contact (hepatitis B), do
not fit neatly into the typical justification for mandatory
vaccination.[94] Nevertheless, public health officials have decided
that recently-developed vaccines for these diseases should be
placed on the recommended schedule. This has given rise to a
significant number of partial exemptors – those who are not
opposed to vaccination requirements per se, but who oppose
particular vaccines on the schedule. Such a position may not have
been comprehended by those who drafted the religious and
philosophical exemptions, which seem to assume that a
parent’s opposition is to vaccination generally, rather than
to a specific vaccine.[95]

Because the religious exemption is usually
constructed to apply to those who oppose vaccination generally
because of sincere religious beliefs, would-be partial exemptors
have difficulty fulfilling their optimal desires. In states without
a philosophical objection, parents must choose either to accept the
entirety of the recommended schedule of vaccines or to obtain a
religious exemption for all vaccinations.[96] Parents who live in states with a philosophical
exemption are much more able to tailor their objection to those
vaccines with which they disagree.[97]

From the standpoint of a public health official,
this presents two possible worlds. In the world with traditional
religious exemptors but no philosophical exemptors, overall
percentages of vaccinations would be relatively equal from vaccine
to vaccine, and higher vaccination rates would be obtained for
diseases associated with more objectionable vaccines at the expense
of lower vaccination rates for diseases associated with less
objectionable vaccines.[98] By contrast, in the world with philosophical
exemptors, the public health official would observe higher
vaccination rates for the less objectionable vaccines and lower
vaccination rates for the more objectionable vaccines.[99]

The difference between these two worlds can have
far-reaching implications. If parents are forced to make the
all-or-nothing choice, a significant enough number could choose to
forego vaccines (including some which they would otherwise accept)
that herd immunity is lost, even for less objectionable
vaccinations. On the other hand, a significant enough number could
accept the more objectionable vaccinations to bring about herd
immunity for those diseases. Though the public health official
might prefer a world in which neither religious nor philosophical
exemptions exist, such a world may not be possible. Therefore, the
official should determine which of the two possible worlds provides
a greater overall level of safety for the society. In addition,
potential public reaction to a vaccine should cause the public
health official to consider the ramifications the addition of a
vaccine to the schedule will have on those vaccines already on the
schedule.

Because partial exemptors have the potential to
sway the balance between herd immunity and vulnerability, public
health officials must take account of their concerns. Unlike in
years past, today the development of a new vaccine presents public
health officials with a choice that can affect other vaccines on
the recommended schedule. Though the possibility for a chickenpox-
and Hepatitis-B-free nation may seem tempting, officials should now
consider the possible consequences of mandating such
“borderline” vaccines. Parents who might otherwise
vaccinate according to the old schedule might have second thoughts
about the new vaccines on the schedule and seek means of avoiding
the new requirements. If no means exist for avoiding the new
vaccines other than complete exemption on religious grounds,
parents who would subsequently pursue such exemptions would bring
about a lower level of immunization for older diseases.

Studies may be necessary in the above situation to
determine whether herd immunity status could be in jeopardy for
those diseases for which vaccines are already on the schedule.
While one solution might be to provide parents with greater ability
to tailor their individual vaccination desires, such a solution
would undermine the efficacy of newly scheduled vaccines. In
addition, greater levels of flexibility in vaccination choice would
undermine public understanding of the community-based nature of
vaccination. I think it might be worth sacrificing the efficacy of
the newer vaccines in order to maintain that of the more
established ones. The public might be willing to suffer the
possibility of chickenpox outbreaks, for example, in order to
prevent an even minor epidemic of diphtheria or the measles.

Again, information should play a key role in the
resolution of this issue. Many of the websites urging parents to
carefully consider the vaccination decision do not inform parents
that their decision to vaccinate may affect the overall health of
the community.[100] The CDC, for its part, does urge parents to
take note of this concern.[101] The very persons who most need to know of
this concern (those seeking exemptions), however, are often those
most likely to distrust CDC publications. For supposed
citizen-oriented websites to urge individuals to make vaccination
choices without considering how such decisions affect the community
is irresponsible, especially given the scientific stability of the
concept of herd immunity.

II. THE ROLE OF THE FEDERAL GOVERNMENT

Some of the problems posed to vaccination programs
by exemptors and others could be partially solved through greater
public awareness of the stringent safety and efficacy testing done
on vaccines before they may enter the market. This section
summarizes the role of FDA in the context of vaccination programs.
In addition, this section will discuss other ways in which the
federal government gets involved in the vaccination issue,
concluding with a brief synopsis of the no-fault compensation
scheme enacted pursuant to the National Childhood Vaccine Injury
Act of 1986.[102]

FDA Regulation

Though state governments determine which
vaccinations are mandatory for school attendance, the federal
government plays a key role in vaccination. Perhaps most
importantly, the federal government regulates the safety and
effectiveness of all vaccines. The FDA’s Center for Biologics
Evaluation and Research (CBER) is charged with this critical
task.[103] The role of CBER ranges from pre-approval
testing of potential vaccines to facility inspection to continued
oversight and sampling after approval.[104] Regulation of vaccines can be more stringent
than for other biologics or drugs.[105] Even after a vaccine is licensed, for
example, FDA oversight is prevalent.[106] Since vaccines are derived from living
organisms and are particularly susceptible to contamination and
other environmental factors, manufacturers usually must submit
samples of each vaccine lot for testing before release.[107]

Before a vaccine can even be licensed for
distribution and use, it must go through an extensive testing
process relatively similar to that of drugs and other
biologics.[108] First, a new vaccine must be tested for
safety on animals.[109] The vaccine manufacturer next must file an
Investigational New Drug application (IND) with the FDA.[110] Studies are then undertaken to ensure safety
before any human testing takes place.[111] In addition, the IND must describe the
studies intended for humans.[112]

Once these initial steps are completed, proposed
vaccines must undergo three phases of clinical trials, in which the
vaccine is tested on humans.[113] Phase 1 testing looks only for very serious
or very common problems.[114] A small number of subjects (usually less than
100) are closely monitored, usually for only a few months.[115] Testing expands in Phase 2 to begin
evaluating efficacy, as well as to further test safety.[116] Phase 2 trials can last up to two years and
typically include hundreds of subjects.[117] The final stage of testing, Phase 3, further
studies safety and effectiveness.[118] Thousands of people may be involved in this
stage of testing, and if successful it can lead to application for
FDA licensing.[119]

Once the clinical trials are completed, the FDA can
examine the results of the tests to determine whether the vaccine
is safe and effective enough to be placed on the market.[120] At any point in the process, the FDA may halt
ongoing studies if safety concerns require such action.[121] The FDA also reviews the data from the
studies and inspects the manufacturing facility.[122] At this point the vaccine may be
licensed.

As stated above, the FDA’s role in protecting
the safety and effectiveness of vaccines does not end at the
licensing stage.[123] Before any vaccines from a particular lot can
be released, the manufacturer must typically submit samples for
potency, safety, and purity testing.[124] Periodic facility inspections also continue
for the duration of the license.[125] Furthermore, formal post-market studies may
be conducted in order to identify problems that would not show up
in pre-market clinical testing.[126] These tests are referred to as Phase 4 tests
and are not mandatory, but can help identify problems that may only
occur very infrequently.[127] Post-marketing surveillance programs are
important because manufacturers are “never going to be able
to do studies big enough to detect risks that might happen at a
level of one in 100,000 or one in 1 million.”[128]

The Vaccine Adverse Event Reporting System (VAERS)
is another valuable tool in identifying problems with a vaccine
once it has been approved for the market.[129] VAERS was developed following
Congress’s enactment of the National Childhood Vaccine Injury
Act of 1986 and has become a very useful tool for identifying
possible adverse effects that would otherwise escape
detection.[130] VAERS allows anyone to report a problem that
may be associated with any vaccine.[131]

It is important to keep in mind that VAERS is
simply a reporting system. Experts and others use the data in VAERS
to attempt to determine whether a vaccine actually causes a
particular adverse effect, but the events that VAERS documents are
not all caused by vaccines. It is therefore easy to understand why
VAERS encourages doctors and others to report any adverse event
that may be related to a vaccine. “VAERS is designed to
detect signals or warnings that there might be a problem rather
than to answer questions about what caused the adverse
event.”[132] It is important to keep these facts in mind
when looking at VAERS data, as many of the adverse effects may be
completely unrelated to the vaccine in question. Often the effects
are correlated with, but unrelated to, vaccination simply because
many of the problems reported are those usually associated with
events happening during the vaccination period (the first few years
of life).[133]

Used correctly, VAERS can lead to useful studies
and the discovery of potentially rare adverse effects.[134] VAERS can also be used to monitor individual
lots of a vaccine.[135] Unfortunately, by encouraging individuals to
report any adverse effect that may possibly have been caused by a
vaccine, VAERS can provide ammunition for those claiming a definite
link between a vaccine and a particular adverse effect, even if the
data is silent on whether such a link exists.[136] While VAERS is in place to help identify
actual risks associated with vaccines, these risks cannot be
accurately assessed solely on the basis of reported incidents of
adverse effects.[137]

The real value of VAERS lies in the testing and
hypotheses that are developed in response to the data that has been
reported. Because of the serious adverse effects already occurring
during the typical vaccination period, it will often be easy and
convenient to point to the correlation between vaccines and
reported adverse events. Lost in the picture is the foundational
proposition that VAERS is, at its core, a data collection system.
To forego scientific inquiry and point instead to simple
correlation may be convenient, but it is unwise.[138]

Thimerosal

The recent public discussion surrounding the use of
thimerosal as a preservative in vaccines helps to illustrate the
importance of the FDA and other factors in furthering the goals of
vaccine safety and public confidence in the entire safety
regulatory process. Thimerosal is a mercury-containing organic
compound that for many years has been used as a preservative in
vaccines to help prevent contamination with microbes that could
potentially be fatal.[139] Recently, fears that mercury at very low
levels may be toxic to the brain have raised concern among many in
the public about allowing the use of thimerosal in
vaccines.[140] Many began to fear a connection between
thimerosal and autism.[141] Standard FDA testing of lots, as well as
studies measuring the amount of mercury contained in the standard
immunization schedule versus accepted safe amounts, did not lead to
safety concerns sufficient to pull thimerosal from the
market.[142] Though one committee (the Immunization Safety
Review Committee, commissioned by the Institute of Medicine)
concluded that a theoretical link between thimerosal and autism was
biologically plausible, most health experts continue to assert that
there simply is no scientific evidence of a link between the
two.[143]

During this time period FDA performed additional
tests to verify or refute the supposed link between thimerosal and
autism.[144] In 1999, FDA performed a comprehensive study
and review of thimerosal use in vaccines for children. This review
revealed no risk from thimerosal use, other than “local
hypersensitivity reactions.”[145] Indeed, none of the standard safety protocols
in place suggested or required that FDA pull thimerosal from the
market. This is not to say, however, that no risk existed. As is
clear from the foregoing summary of FDA vaccine approval, not all
adverse effects will be known from clinical trials.[146] It may take years or longer to assess some of
the risks of vaccines, including the risk of thimerosal as a
preservative.[147]

Continued public concern over the safety of
thimerosal caused FDA to begin to work with vaccine manufacturers
in order to reduce or eliminate thimerosal from vaccines as a
precautionary measure.[148] About this time, the American Academy of
Pediatrics and the Public Health Service urged the removal of
thimerosal from vaccines.[149] Today, with the exception of the inactivated
influenza vaccine, all recommended childhood vaccines are either
thimerosal free or contain only trace amounts of the
compound.[150] Even though the risk may not have been as
great as feared by the public or even existent at all, if the new
vaccines are equally effective, the elimination of thimerosal from
vaccines can probably be seen as a safety improvement, albeit at
the expense of the added research and development needed to create
the new thimerosal-free vaccines.

Rather than quell the existing safety concerns,
this action led many of those who had decried the use of thimerosal
to accuse FDA of participating in a cover-up to protect vaccine
manufacturers.[151] Government agencies, for their part, continue
to claim that vaccines with thimerosal are as safe as
thimerosal-free vaccines, suggesting that the added development may
have been superfluous.[152] While this may be so, the availability and
now prevalence of thimerosal-free vaccines does provide the
scientific and medical community with a new means of assessing the
possible autism-causing effects of thimerosal. Namely, since
thimerosal is suspected to cause autism within the first few years
of life (the routine vaccination calendar), those who were
vaccinated in the years since thimerosal-free vaccines have
comprised the overwhelming majority of vaccines (that is, those
born after 2001) would be expected to experience lower incidences
of autism than the groups vaccinated with thimerosal-containing
vaccines.[153]

In spite of the potentially costly decision to
encourage the development of thimerosal-free vaccines when there is
no sufficient safety concern to pull thimerosal from the market,
FDA and other government officials have had little success in
assuaging the fears and concerns of thimerosal critics.[154] Scientific arguments often fail to persuade,
either because they are inconclusive or because of a perceived bias
favoring vaccine manufacturers.[155] To back up their own arguments, thimerosal
critics rarely point to scientific studies.[156] Instead, their reasoning seems to stem more
from anecdotal evidence and comparison of thimerosal (which
contains ethyl-mercury) to methyl-mercury-containing fish.[157] Representative Dan Burton (R-Indiana), a key
supporter of the fight against thimerosal, explained that his
belief in the toxicity of thimerosal stemmed from a personal
episode: “[m]y grandson received nine shots in one day, seven
of which contained thimerosal, which is 50 percent mercury as you
know, and he became autistic a short time later.”[158] Others point to the rise in autism rates in
the past twenty years and put the onus on the medical community to
prove that this rise is not due to thimerosal.[159]

The response of health officials has been to ask
why the burden should be placed on them to disprove a link between
thimerosal and autism; cell phones, ultrasound, or diet soda could
just as easily be the culprit.[160] Indeed, the typical response to those
charging vaccination with causing many of the adverse effects
occurring in life’s first few years is to point out that
usually such accusations are based on nothing more than the
temporal proximity of the vaccine and the illness. Some have
suggested that the rates of autism may be on the rise not because
of thimerosal, but because of generally more accurate diagnosis of
the affliction.[161] In the past, an autistic child may have been
wrongfully diagnosed with other mental disorders.[162] Figures showing a correlation between the
rise in autism and the drop in other diagnosed mental disorders
bolster such assertions, and suggest that vaccination may simply be
a convenient scapegoat.[163]

As the thimerosal issue makes clear, vaccines often
provoke strong feelings amongst various segments of the
population.[164] Proper consideration of public reaction to
its actions is a delicate aspect of FDA regulation of vaccine
safety. To complicate matters further, one can easily imagine an
equally vehement response and similar claims of conspiracy had the
FDA not worked to reduce thimerosal from vaccines as a
precautionary measure. Indeed, public confidence in the safety of
vaccines is often influenced by factors outside the typical FDA
calculus. Though FDA must act in the interests of the general
safety regardless of public opinion, it may sometimes be necessary
for FDA to consider public opinion, at least when exercising
discretionary oversight. After all, the entire VAERS system is to a
large extent dependant on public cooperation. Nevertheless, when
the choice is between FDA popularity and doing what is right for
the safety of Americans, the FDA should not allow itself to be
swayed by a misinformed public.

Vaccine Injury Compensation Program

Congressional reaction to safety concerns goes
beyond the adverse reporting system VAERS. The National Childhood
Vaccine Injury Act of 1986, which created VAERS, also created a
no-fault compensation scheme for people injured or killed by
vaccines as an alternative to the traditional tort system.[165] This system was intended to efficiently and
rapidly compensate those who are actually injured by vaccines while
maintaining an environment in which further vaccine research and
safety improvement could exist. The situation giving rise to this
compensation program sounds remarkably similar to the more recent
concerns surrounding thimerosal:

In the early 1980's, reports of harmful side
effects following the DTP (diphtheria, tetanus, pertussis) vaccine
posed major liability concerns for vaccine companies and health
care providers, and caused many to question the safety of the DTP
vaccine. Parents began filing many more lawsuits against vaccine
companies and health care providers. Vaccination rates among
children began to fall and many companies that develop and produce
vaccines decided to leave the marketplace, creating significant
vaccine shortages and a real threat to the Nation’s
health.[166]

Funding for the no-fault compensation scheme
initially came from Congressional grants of federal tax dollars
totaling $110 million per year.[167] Since October 1, 1988, funding has proceeded
from the Vaccine Injury Compensation Trust Fund, which is funded by
a $0.75 excise tax on all doses of vaccines covered under the
program.[168]

One may wonder what makes vaccines worthy of an
alternative dispute resolution system. Perhaps it is the result of
the power of the vaccine manufacturing lobby or simply an attempt
by Congress to pass some legislation in the face of strong public
sentiment. Although these reasons may appear plausible, it seems
more likely to me that the Act created this no-fault compensation
scheme because of the mandatory nature of vaccination. For those
injured by other medical devices or drugs, the traditional tort
system or medical insurance seem the proper means of addressing the
issue. When people are told to undertake a medical procedure they
may not agree with because it helps further a public goal, however,
it may make sense to have a system in place whereby they can obtain
relief quickly if harmed by the procedure. Moreover, because
certain vaccines may be closely associated with particular adverse
effects, the efficiency of a no-fault scheme may trump the standard
fact-finding processes of the legal system. The government has
chosen to enact such a no-fault scheme, and err on the side of
compensation.

III. ANALYTICAL MEANS OF ADDRESSING THE ISSUE

The concerns and problems raised in the context of
mandatory vaccination programs do not readily suggest a simple
answer. In examining the issue, I came across two particularly
useful tools for analyzing the problem. The first comes from an old
episode of The Andy Griffith Show in which a local farmer refused
to accept a vaccination from the local nurse. In addition to
providing substantial entertainment to the viewer, the characters
can be viewed metaphorically to represent the various parties in
the mandatory vaccination debate. The episode’s solution, in
turn, sheds some light on the current debate.

This section will also utilize the analytical
framework of economic analysis. Though not as enjoyable a topic as
The Andy Griffith Show, economic theory helps to reshape the
vaccination discussion and greatly facilitates the process of
assessing the various positions.

The Andy Griffith Show addressed the concept of
popular resistance to universal vaccination over forty years ago.
In “The County Nurse,” Sheriff Andy Taylor confronted a
local nurse who was trying to bring everyone up to date on their
tetanus shots. Not surprisingly, at least to Andy, many of the
mountain farmers had not been inoculated. The naïve nurse
would soon discover the reason for the low vaccination rate.

Rafe Hollister, one of the leading farmers in
Mayberry, had little use for modern medicine or doctors in general.
“We don’t need any nurse, nobody gets sick up
here.”[170] Thermometers? “I know when I got a
fever, I’m hot.”[171] Stethoscopes? “I know my heart’s
beating, I’m alive ain’t I?”[172] But his strongest objection was saved for
vaccinations: “I ain’t never been jabbed and I
ain’t fixin’ to be.”[173] Such were the views that the nurse was up
against in her attempt to achieve 100% vaccination rates.

Rafe Hollister

Rafe Hollister’s reasons for opposing
vaccination went beyond his desire to avoid getting
“jabbed.” He was a farmer who lived off the land, and
when he got sick he let his body fight the sickness naturally. His
daddy had lived to the age of hundred and he aimed to do the
same.[174] The concept of a vaccination was certainly
something foreign to him, as was the idea that a health official
could force him to do anything. Even in the wake of the
nurse’s impassioned plea to accept a shot that could someday
save his life, he retorted simply, “I done alright before you
come around and I’m doing alright now.”[175]

Although the county nurse was not acting pursuant
to a mandatory vaccination program, under the circumstances her
attempts to get Rafe inoculated were pretty forceful. The nurse was
accompanied by the local sheriff to Rafe’s farm to try to
convince him to take the shot, and when he refused, the sheriff and
nurse continued to attempt to make him acquiesce. When Deputy
Barney Fife heard of Rafe’s stubbornness, he insisted the
nurse return to Rafe’s farm with him to force Rafe to take
the shot. After all, boasted the deputy, “Rafe
Hollister’s like a child and he’s gotta be treated like
one...I’ll make him take his shot.”[176] When the deputy arrived at Rafe’s farm
yelling that he was forcing Rafe to accept the vaccination, Rafe
decided to fight the mandatory vaccination by drawing his rifle and
forcing the deputy to leave the farm.

In a classic manifestation of the early spirit of
the television series, Sheriff Andy Taylor finally convinced Rafe
to take the shot through a little reverse psychology. Andy began by
facetiously praising Rafe’s refusal to take the shot as
stemming from Rafe’s desire for immortality. Namely, by
refusing to take the shot, Rafe was sure to become the impetus for
all the other townspeople not to neglect to take their shots.
Unfortunately for Rafe, this heroic stature would only be achieved
posthumously, as he will have succumbed to a violent and painful
death from tetanus. As Andy explained to Rafe, someday, after
getting cut by a rusty saw or bitten by an animal, without the shot
he’ll “be a cinch to go.”[177] Eschewing the chance to be a dead hero, Rafe
finally took the shot.

Sheriff Andy Taylor

Vaccination has changed the modern world. Indeed,
it has led to the elimination or significant decline of many
diseases that once posed significant and potentially deadly health
risks. Public health officials in the United States have managed to
institute a program that, though subject to variations on a state
by state basis, essentially mandates certain vaccinations as a
requirement for school attendance. While these vaccination programs
are touted by most public health officials, a significant number of
people oppose mandatory vaccination. The County Nurse episode helps
illuminate the perspectives of the various sides of the issue, as
well as one possible solution.

The nurse herself represents the public health
officials. Though she is not implementing a mandatory vaccination
program, her stated goal is to inoculate 100% of the
population.[178] As mentioned above, she has the assistance of
local law enforcement and she is quite persistent. Rafe Hollister,
the stubborn farmer, represents those within the community who
oppose or resist mandatory vaccination programs. His reasons
initially rest on a general reluctance to stray from natural
medicine. In this way he represents the contingent of society that
scientists and medical researchers will always find difficult to
convince of any developments in the medical field. In many ways, he
is comparable to the plaintiff in Jacobson . Andy and Barney
can be seen as the arms of the state that are entrusted with
carrying out the general vaccination plan. Their varying styles can
be seen as varying state requirements and enforcement options for
vaccination.

Though these comparisons may seem elementary and of
little value, the character development that the characters
undertake during the episode greatly increases the episode’s
usefulness as a surrogate for real world concerns and issues. Rafe
resists the shot initially not only because he distrusts medicine
in general, but also because he resents the idea that a county
nurse can make him do anything. Many who resist mandatory
vaccination schemes do so because of personal liberty concerns;
they do not want the government to tell them what to do, especially
in the context of personal medical decisions. Just as Rafe’s
stance becomes more vehement the harder the nurse attempts to
convince him, many who oppose mandatory vaccination see the
persistence of the medical community as evidence of blind adherence
to a potentially dangerous system, or worse yet as an active
promotion of the special interests of the vaccine
manufacturers.[179] The episode does not paint the nurse in this
way at all, however. Rather, after seeing how strongly Rafe opposes
vaccination, the nurse passionately pleads with him to reconsider.
Her stance truly seems to stem from a genuine concern that he not
suffer the potentially terrible effects of the disease.[180] As before, he refuses; this seems to
illustrate that the stance of some may be so strong that they will
never accept vaccination on the basis of arguments advanced by
government officials.

Barney Fife’s insistence that Rafe accept the
shot demonstrates the lack of understanding among many in the
government and in the general population as to the vehemence with
which those opposing mandatory vaccination hold to their views. His
paternalistic stand only serves to exacerbate the situation with
Rafe. Indeed, Barney Fife helps to illustrate that there cannot be
a one-way solution to the issue of mandatory vaccination.

Andy Taylor’s method of convincing, which
eventually carried the day, may not be very conducive to real-world
implementation. After all, it is unrealistic to think that reverse
psychology will convince those currently opposed to vaccination
programs to change their minds. What I think is important to
notice, however, is the role information can play in this issue.
Andy finally convinces Rafe Hollister to take his shot after
describing the horrible effects of the disease and how likely Rafe
is to contract it. Similarly, any solution to the issue of
mandatory vaccination holdouts must rely on increased information
dissemination. That the information in the episode came from a
trustworthy source may also have been crucial, which seems to imply
that public health officials may need to work more closely with
local personnel in order to obtain higher vaccination rates.

Because this episode deals with the vaccine for
tetanus, a non-communicable disease, the usual community-based
arguments in favor of vaccination do not enter the equation.
Extra-personal consequences of Rafe’s decision to vaccinate
do exist, however. Most importantly, as the unofficial leader of
the farming community, his decision will be followed by the other
farmers. This is shown both in Andy’s assurances to the nurse
that Rafe is the most important of the farmers to convince on the
issue and later, after Rafe has decided to get the shot, in his
promise to the nurse that all she has to do is come with him and
he’ll get all the farmers to take their shots. Perhaps those
parents who support vaccination can help bring about higher
vaccination rates by being more vocal and persistent with their
neighbors who oppose vaccination programs.

Economic Analysis

Economic analysis[181] provides a useful theoretical basis for
evaluating the competing sides of the vaccination debate. Arguments
regarding the wisdom of the current vaccination policy can often be
recast as economic questions involving a cost-benefit analysis.

When an epidemic breaks out, for example, the
benefits of vaccination (protection from the disease both for the
individual and for society through herd immunity) seem more clearly
to outweigh the costs (potential side effects of the vaccine,
decreased ability of the immune system to defend the body from
variant strands of the disease, or personal or religious
objection). Vaccination rates would, therefore, be expected to be
highest during such epidemics. Consequently, those few who continue
to oppose vaccination during such epidemics would be expected to do
so for only the strongest reasons. This is due to the fact that in
economic terms, the opponent of vaccination would have to believe
that the benefits of vaccination still do not outweigh the costs,
even during an epidemic. This might stem from a relative
undervaluation of the benefits of vaccination (perhaps due to a
belief that contracting the disease would not be so bad) or a
relative overvaluation of the costs of vaccination (possibly due to
the greater cost to the conscience of the personal or religious
opponent of vaccination) or some combination of both. Medical
exemptions directly illustrate this cost-benefit analysis: for a
person likely to suffer serious side effects from a vaccine, the
cost of vaccination is much greater than the cost to the average
individual. Even in a time of epidemic, therefore, vaccination
might not be rational for such an individual.

Jacobson

This economic analysis of vaccination is well
illustrated by the facts of Jacobson v. Massachusetts[182] , the first Supreme Court case addressing the
constitutionality of mandatory vaccination legislation. The case
involved a Massachusetts statute allowing local authorities to
mandate vaccination for smallpox if necessary for the public health
and safety.[183] Subsequently, and upon a determination that
smallpox was “prevalent to some extent” and
“continues to increase,” the city of Cambridge passed a
mandatory vaccination ordinance.[184] This ordinance represented the economic
determination that the benefit of mandatory vaccination outweighed
the cost of supplying vaccines, finding and prosecuting holdouts
(such as Jacobson), and the decreased liberty of individuals to be
permitted to decide whether to vaccinate.

Jacobson subsequently challenged his prosecution
under the ordinance by claiming it to be an unconstitutional denial
of his liberty under the 14th Amendment (as well as in violation of
the Preamble and the “spirit” of the Constitution,
arguments that were summarily dismissed).[185] In economic terms, this may simply indicate
that he viewed the cost of accepting a forced vaccination (perhaps
of any kind, in any circumstance) as greater than any possible
benefit. A closer look at his arguments, however, suggests that he
may have performed a more detailed cost-benefit analysis. One can
easily convert the various arguments he attempted to advance into
economic costs. Among these arguments were the likelihood of
vaccination to bring about “serious and permanent
injury” and occasional death, the inability of an individual
to assess the risk of vaccination in a particular case, and the
potential impurity of vaccines and inability to test such impurity,
among others.[186] At the very least, it would appear that
Jacobson attributed a greater than average cost to vaccination.

The statute also provided that ordinances mandating
vaccination provide an exception for “children who present a
certificate, signed by a registered physician, that they are unfit
subjects for vaccination.”[187] This reflects the state’s determination
that the cost of forcing vaccination upon those more likely to
suffer adverse side effects outweighed the benefit of completely
universal vaccination. Given the determination that near-universal
vaccination was required to provide the desired benefit, one would
expect that the state expected to grant relatively few medical
exemptions (or at least few enough not to seriously compromise the
goal of providing protection against smallpox through
vaccination).

In rejecting Jacobson’s liberty challenge to
the ordinance, the Court endorsed the concept that the
State’s cost-benefit analysis can supersede that of the
individual, at least in the area of public health. The
Court’s decision, in fact, makes irrelevant any individual
cost-benefit analysis in the face of a comprehensive mandatory
vaccination program.

Various vaccination-related developments in the
century since Jacobson can also be cast in an economic
analytical framework. Certainly the benefit from vaccination
disappears when a disease has been eradicated, which explains why
the smallpox vaccine is no longer mandated. Any cost greater than
zero (the likely benefit of smallpox vaccination at this point,
barring of course a reintroduction of the disease using laboratory
samples) will suffice to outweigh this benefit.[188] The success of vaccination policies, however,
may lead to an undervaluation of the benefit of continuing to
vaccinate due to the lack of visible instances of the
disease.[189] This problem may be compounded when vaccines
are mandated for diseases which are not associated with high
mortality rates, such as chickenpox. A further complication to the
cost-benefit analysis arises when assessing vaccination policy for
diseases such as Hepatitis B, which is spread typically through
voluntary contact. In such a case, an individual who feels highly
unlikely to engage in the behavior giving rise to the risk of the
disease might rationally see very minimal benefit from vaccination,
while the state may view widespread vaccination as the most
cost-effective method of dealing with the disease.[190]

Altruism and Free Riding

Given the continuing policy of vaccinating for
diseases that have become relatively rare in recent decades, one
might expect individual cost-benefit analyses to increasingly come
into conflict with the societal policy. Several factors, however,
serve to counteract this possibility. Perhaps most significantly,
it is likely that many parents defer on the question of vaccination
and accept the cost-benefit analysis of the state (communicated to
the individual through the vaccination schedule and through
doctor’s recommendations) as their own. Along the same lines,
many individuals might not strongly consider the pros and cons
involved in vaccinating; if the possibility exists for contracting
a disease, and a vaccination is available, the decision may already
be made.[191] A third possibility implicates a factor that
I have not yet mentioned in relation to the individual cost-benefit
analysis: altruism.

Some have proposed that altruism may bridge the gap
between incompatible cost-benefit analyses of states and
individuals.[192] Whereas typical medical decisions affect only
the patient making the decision, it is pointed out, medical
decisions regarding vaccine-preventable diseases usually implicate
outside interests.[193] A patient thinking only of his own interests
may forego vaccination if he feels the risk from vaccination
outweighs the personal benefit. Altruism, it is argued, may present
a separate benefit for such an individual.[194] Though the individual may not consider the
risk of contracting the disease high enough by itself to justify
vaccination, he may still vaccinate in order to help accomplish the
public goal of eliminating the threat of an epidemic. Public health
officials hope that comprehensive vaccination will produce herd
immunity.[195] Thus the individual who may otherwise forego
vaccination might undertake it in order to “do his
part” for the community at large. Individuals who cannot
vaccinate are particularly dependent on this sort of altruistic
behavior, as they often have no other protection from the
disease.[196]

Working against this altruistic behavior is the
temptation of individuals to enjoy the benefit conferred on them by
herd immunity without undertaking the cost of being vaccinated
personally.[197] This is widely referred to as “free
riding,” and greatly undermines the goal of comprehensive
vaccination. Since herd immunity is supposed to create a level of
protection sufficient for even those few who are not vaccinated, a
small number of free riders might not pose a significant problem.
As described earlier in this paper, comprehensive vaccination
programs are designed to work even though some members of society
cannot be vaccinated.[198] The problem arises when the number of free
riders becomes sufficiently high to compromise the ability of the
society to achieve herd immunity. Since the average citizen (one
with no greater reason to avoid vaccination than any other member
of society) could always choose to free ride if immunization were
voluntary, herd immunity might never be achieved. This is one of
the key arguments advanced in support of government mandated
vaccinations.[199]

Ex Ante Versus Ex Post

The concepts of altruism and especially free riding
emphasize the importance of ex ante (before the fact) versus ex
post (after the fact) decision making in the context of
vaccination. One of the main benefits of economic analysis is that
it requires decisions to be justified ex ante. Public health
officials, for example, are faced with the decision of whether to
mandate vaccination for a particular disease at a time when all
adverse effects cannot be known. They must weigh the possible
consequences of allowing a disease to continue against the possible
known and unknown adverse effects of a vaccine that may have just
entered the market. When this decision is made properly, the
benefit of the vaccination program will have outweighed the cost.
The benefit is manifested in lower or no occurrences of the
disease, while the cost is seen most directly in those children who
have actually experienced adverse effects as a result of the
vaccine. If the benefit is greater than the cost from an ex ante
perspective, to the economist there should be no second-guessing of
the vaccination program.[200]

The economist, of course, is not the parent.
Parents who decry mandatory vaccination as the cause of their
child’s adverse reaction are typically viewing the situation
ex post. That the program has been implemented assumes that the sum
of these adverse reactions was an acceptable alternative to
non-implementation, and should therefore not be allowed to
undermine public confidence in the program. When one surveys the
landscape of the vaccination issue, however, objections are usually
of the ex post variety. Since it is harder to appreciate the
absence of an epidemic than the presence of a child suffering a
vaccine-related injury, it is easy to look at the issue solely ex
post. In the interests of public safety, such reasoning should be
avoided.

This is not to imply that all critics of mandatory
vaccination are on unsound theoretical footing. In fact, those
whose objections are marked by a distrust of the government
authorities in charge of implementing vaccination programs can be
seen as questioning only the ex ante judgment of the officials. If
this is so, they are actually on firmer ground than those who
object to the programs because they feel their child was harmed by
the vaccine. Ex ante critiques are valuable because they can bring
about change in the system at a time when it can still prove
useful.

The National Vaccine Injury Compensation Program
represents a theoretically sound program under these criteria.
Economically, it represents the idea that some of the costs of
mandatory vaccination programs known only ex post will be
compensated by all those who share the benefits ex ante. The excise
tax, paid ex ante by all who receive the vaccine, is used to
compensate anyone who experiences certain adverse effects ex post.
This is simply an example of the government distributing the costs
of the vaccination program across the spectrum of those who receive
the benefit, rather than an ex post complaint by those on whom the
costs have fallen.

Other Issues

The modern trend toward more widely-granted
exemptions represents government acquiescence toward a certain
degree of free riding. Should such exemptions proliferate too
widely, herd immunity may indeed be lost and a recalculation of the
cost-benefit analysis of individuals will be necessary. In the face
of a greater potential to contract disease, the benefit of
vaccination grows significantly, while the cost of accepting the
vaccine remains the same. Likewise, from the standpoint of the
government, the cost of allowing widespread exemptions will
eventually overtake the benefit of permitting such exemptions if
that cost suddenly includes serious risk of epidemic.

The risks associated with non-vaccination can be
illustrated through a rather simplified mathematical
example.[201] Suppose a school with 1,000 students is
exposed to a measles outbreak. 990 of the students have received
all of their measles shots, and so are fully immunized. Suppose
further that the measles vaccine is 99% effective; that is, it
produces complete immunity in 99% of patients.[202] Therefore, 10 out of the 990 who have been
fully immunized will be susceptible to the disease. In addition,
all 10 of the 1,000 students who had not been fully immunized will
be susceptible to measles. Therefore, 20 out of 1,000 students will
get the disease. Although the number of infected students who were
vaccinated is equal to the number who were not, this example
demonstrates that vaccination can be very effective even if it
sometimes does not produce immunity in an individual. If no one had
been vaccinated, 980 more students would probably have caught the
measles. It is also important to note that this example assumes an
epidemic; in reality, herd immunity would probably be attained at
this level of inoculation and none of the 1,000 students would have
caught the disease.

IV. CONCLUSION

Vaccines have immeasurably improved our quality of
life. They have led to the eradication of deadly diseases like
smallpox and the near elimination of diseases such as diphtheria,
polio, and measles. Outbreaks of vaccine-preventable diseases, such
as mumps, are infrequent and are also quite newsworthy on the rare
occasion that they do occur. And people like Rafe Hollister can
survive a run-in with a rusty saw or an animal bite.

The life-saving benefits of vaccination often
overshadow the vast economic and personal benefits it has helped
provide. Jonas Salk’s cure for polio has spared generations
from a life hindered by the devastating physical handicaps of that
terrible affliction. Children no longer must miss vast stretches of
school to overcome a debilitating battle with pertussis (although
there is no doubt that some children lament this decline in excused
absences from school). Parents no longer have to spend restless
hours worrying as their children suffer the body’s natural
response to disease. In economic terms, this translates directly
into fewer missed hours of work and less administrative difficulty,
leading to a generally more productive society.

Jonas Salk

For all the benefits of vaccines, of course, it is
important not to ignore the costs. The National Vaccine Injury
Compensation Program is one way of dealing with the economic costs
of vaccination, but this may provide little solace to the parent of
a child who has been injured by a vaccine for a disease that is
seemingly in decline. Side effects with very low probability will
sometimes occur; though from a community-wide view this possibility
is acceptable, for the individual who experiences the adverse
effect the vaccination may not have been the best medical decision.
Many who view natural immunity as a rite of passage for children
might not desire a means of bypassing the disease entirely.

Some may accuse public health officials of dreaming
for an unreachable day when all diseases are controlled by
vaccination. Zeal on the part of public health officials, however,
should not overshadow the actual benefits of vaccination generally.
Soon may come the day when diphtheria, like smallpox, will be
eradicated globally. At that point, it can be removed from the
vaccination schedule and future generations will reap the benefits
of vaccination while undertaking none of the costs.

This prospect, I think, sheds light on the ultimate
solution to vaccination issues that have been discussed in this
paper. Highly communicable and especially terrible diseases should
continue on the vaccination schedule until they are virtually
eliminated. The eventual elimination of these scourges will someday
make vaccination unnecessary, and the costs of vaccination will
drop to zero. Until that time, officials should seek stricter
enforcement of the mandatory vaccination laws and should tighten
down on non-medical exemptions. At the same time, information
campaigns should be considered in the interest of reminding the
public of the continued importance and relevance of vaccine
programs. Though risks are unavoidable when dealing with vaccines,
parents should constantly be reminded that immunity depends on a
high level of cooperation. This will hopefully keep immunization
rates high, at least for the most harmful diseases.

Meanwhile, public health officials may be wise to
consider an alternate stance toward somewhat less-important
vaccines such as Hepatitis B and varicella (chickenpox).[203] With such diseases it may be worthwhile to
wait longer before placing the vaccines on the recommended
schedule. This will undoubtedly make herd immunity more difficult
if not impossible to attain, while simultaneously announcing to
parents that undertaking the vaccine in question is a personal
medical decision. Most of those who choose to vaccinate (and accept
the risk of adverse effects from these newer vaccines) will still
acquire immunity. Without a mandatory program in place, however,
one would still expect to see regular occurrences of the disease.
Given the relatively high likelihood of outbreak under these
circumstances, a percentage of those who vaccinate will probably
get the disease. They will likely turn to those who did not
vaccinate at all and see them as the cause of the outbreak. In
time, social pressures may lead to greater vaccination rates, and
the time may be ripe for greater acceptance of mandatory
vaccination for the disease.

One significant benefit to this approach lies in
its natural tendency to point out to parents the importance of
receiving the more important vaccines. When some vaccines are
mandatory and others are not, the distinction between the two types
of vaccines is impossible to neglect. It would hopefully make
parents think more carefully before attempting to gain an insincere
exemption. This approach would fail to satisfy those who want
parents to have the option to choose “one, ten, or no
vaccines,”[204] but it would at least allow an element of
choice for some vaccines while hopefully maintaining a sufficient
level of immunization for the more important vaccines. It is also
important to remember that parents with serious reservations about
any vaccines will usually have the option of home schooling.
Overall, this approach might have the advantage of winning over
those who only partially object to the vaccination schedule, thus
helping bring about a greater chance of herd immunity for diseases
associated with less objectionable vaccines.

Vaccination certainly is unique among medical
treatments, both for its incredible potential and its coercive
nature. It is unfortunate that questionable evidence has led many
concerned parents to question the wisdom of vaccination programs
that still serve important goals. Given the importance of public
support for the achievement of these goals, however, public health
officials must account for sometimes questionable concerns in
determining vaccination policy. Greater information dissemination,
combined with more sharply drawn (and potentially vaccine-specific)
guidelines, can hopefully further the important goals of
vaccination policy.

[8] “Rather than having health departments require
immunization in emergency conditions, legislatures acted to prevent
disease by mandatory immunization as a condition of enrollment or
attendance in schools or licensed day care facilities.”
Id.

[9]See id. ; see also infra Part I (chart
describing the current recommended vaccination schedule).

[10] The Center for Disease Control has gone so far
as to suggest that “to have a medical intervention as
effective as vaccination in preventing disease not use it would be
unconscionable.” Center for Disease Control, National
Immunization Program publication, “Six Common Misconceptions
About Vaccination and How to Respond to Them,” at
http://www.cdc.gov/nip/publications/6mishome.htm (last visited
April 27, 2006) (hereinafter “Six Common
Misconceptions”).

[11] Center for Disease Control, National
Immunization Program publication, “Ten Things You Need to
Know about Immunizations,” at
http://www.cdc.gov/nip/publications/fs/gen/shouldknow.htm (last
visited April 27, 2006).

[12] This is not to imply that parents who vaccinate
without carefully considering the pros and cons of vaccination are
in the wrong. The health and safety of a child is of paramount
importance to most parents, and every parent must make decisions
that affect the welfare of the child. Most parents approach such
decisions with a sincere desire to promote the child’s best
interests, and this desire is no different in the context of
vaccination.

[13] “Despite its utility, vaccination has
provoked popular resistance from the beginning.” Hodge and
Gostin, supra note 4, at 834.

[14] “Some opponents express valid scientific
objections about effectiveness or need for mass vaccinations; some
fear harmful effects arising from the introduction of foreign
particles into the human body; and others worry that vaccination
actually transmits, rather than prevents, disease, or weakens the
immune system.” Id.

[15]See, e.g. , Jacobson v.
Massachusetts , 197 U.S. 11 (1905) (constitutional challenge to
government mandated smallpox vaccination); “Six Common
Misconceptions,” supra note 10 (“[s]ome see
mandatory vaccination as interference by the government into what
they believe should be a personal choice”).

[29] This level of immunity is often referred to as
“herd immunity,” the concept that not everyone in a
population must be vaccinated in order for the entire population to
be protected. Abi Berger, “How Does Herd Immunity
Work?” 319 BMJ 1466 (1999). “As long as a sufficient
number of children are immunised against each disease for which
there is a vaccine, protection against that disease will be
conferred on everybody.” Id. Also, the level of
vaccination necessary to attain herd immunity increases as the
infectivity of the disease increases. Id. Highly infectious
diseases, therefore, require higher levels of immunity for herd
immunity to occur. Id. The concept of herd immunity will
arise throughout this paper, with particular emphasis in Part
III.

[30] This is evidenced by the fact that in time of
outbreak, the vaccinated population can still be susceptible to the
disease, although usually the vaccinated population is far less
susceptible to the disease than the unvaccinated population.
Vaccines typically produce the desired antibody in an individual
around 90% of the time, with actual percentages varying from
vaccine to vaccine. Some vaccines, moreover, lose their efficacy
and require boosters. These concepts will be further developed
throughout this paper.

[51] The schedule of immunizations is published by
the Center for Disease Control, and follows the recommendations of
the Advisory Committee on Immunizations Practices, the American
Academy of Pediatrics’ Committee on Infectious Diseases, and
the American Academy of Family Physicians. Id.

[54] Based on chart publicized by Center for Disease
Control, approved by Advisory Committee on Immunization Practices,
American Academy of Pediatrics, American Academy of Family
Physicians, available at
http://www.cispimmunize.org/IZSchedule_2006.pdf (last visited April
27, 2006).

[58] The most direct way in which this occurs
surrounds the concept of herd immunity, as discussed elsewhere
throughout this paper. If a sufficient number of persons in the
community does not vaccinate, herd immunity may be unattainable and
others may be put at risk.

[59]See, e.g. , the discussion in Part III
involving The Andy Griffith Show.

[67] As the discussion in Part II on vaccine safety
demonstrates, pre-licensing testing for very rare adverse effects
cannot take place if vaccines are ever to reach the market. Phase 4
post-licensing testing does exist, but may take years to discover
extremely rare adverse effects.

[69] As the recent mumps outbreak in Iowa
demonstrates, not everyone who receives a vaccine develops immunity
to the disease. For this reason, the success of vaccination depends
on a sufficient level of vaccination in the community. When a
significant percentage of the population has not received the
vaccine, an outbreak can occur and even threaten some of those who
have been vaccinated. See David Pitt, “Iowa Mumps
Epidemic Continues to Broaden,” Associated Press, April 13,
2006, at
http://www.breitbart.com/news/2006/04/13/D8GVGL600.html (last
visited April 27, 2006). See also the above discussion of the
history of vaccination.

[A]s risks of contracting many deadly and crippling
diseases continue to decline to near negligible levels, and rates
of childhood immunization continue to reach record levels, the
public today places greater attention on the relative weaknesses
and dangers of immunizations, and the systems through which they
are administered.

[74] Indeed, the CDC itself presupposes the existence
of medical exemptors in any broad mandatory vaccination program.
See “Six Common Misconceptions,” supra
note 10 (noting that the mandatory vaccination program can work to
protect even those few who cannot vaccinate because of the
possibility of adverse medical reactions).

[79]See, e.g. , Boone v. Boozman , 217
F.Supp.2d 938 (E.D. Ark. 2002). The challenged Arkansas
immunization statute exempted “individuals for whom
‘immunization conflicts with the religious tenets and
practices of a recognized church or religious denomination of which
[they are] an adherent or member.’” The statute was
struck down under the Establishment Clause using the test laid out
in Lemon v. Kurtzman , 403 U.S. 602 (1971). 217 F.Supp.2d at
950. The Arkansas legislature subsequently amended the exemption
generally to allow for religious or philosophical objections
without regard to recognized churches. Ark. Code Sec.
6-18-702(d).

[90]Id. The recent mumps outbreak may
directly demonstrate this. Officials have pointed out that
vaccination only confers immunity on 95% of patients, and of those
affected in the recent outbreak, 25% have been vaccinated.
See Pitt, supra note 69. The strong implication is
that the 75% of those inflicted who were not vaccinated have put
the entire community at risk.

[91] Center for Disease Control, National
Immunization Program publication, “What Would Happen If We
Stopped Vaccinations?” at
http://www.cdc.gov/nip/publications/fs/gen/WhatIfStop.htm (last
visited April 27, 2006).

[93] Silverman suggests that eliminating
philosophical and religious exemptions would do more harm than
good. This approach, he believes, “would exacerbate feelings
of animosity and skepticism toward vaccination and the public
health system in general.” Id. at 293. On this score
he is probably correct, and I agree that wider knowledge, at the
very least, is a better initial response to this problem.

[94] Incidentally, it is worth mentioning that of the
more longstanding vaccines, the tetanus vaccine stands out as
unique. Tetanus is a very harmful disease with about a 20% fatality
rate. “What Would Happen If We Stopped Vaccinations?”
supra note 91. What makes it unique in the vaccine schedule
is that tetanus is not contagious. That is, herd immunity is not
attainable and cannot be used to justify mandatory tetanus
vaccination. The reason for the general acceptance of the tetanus
vaccine seems to stem both from the high risk of the disease and
the fact that tetanus can only be prevented by immunization. In
addition, the tetanus vaccine for infants has been combined with
the vaccines for diphtheria and pertussis. On strictly public
health grounds, however, the status of the tetanus shot on the
compulsory vaccination schedule comes closest to government fiat of
individual health decisions.

[95] Because medical risks may vary from vaccine to
vaccine, and thus the justification for such exemptions remains
even if the risk is to some but not all vaccines, medical
exemptions are somewhat outside the scope of this discussion.

[100]See, e.g. , National Vaccine
Information Center, at http://www.nvic.org (last visited
April 27, 2006) (urging parents to consider eight questions before
vaccinating, none of which inform parents of the effect their
decision may have on others).

[123] Indeed, the National Immunization Program has
confidently pointed to the FDA’s role in continued oversight
of vaccines:

FDA would recall a lot of vaccine at the first sign
of problems. There is no benefit to either the FDA or the
manufacturer in allowing unsafe vaccine to remain on the market.
The American public would not tolerate vaccines if they did not
have to conform to the most rigorous safety standards. The mere
fact that a vaccine lot [is] still in distribution says that the
FDA considers it safe.

[136]See, e.g. , “Six Common
Misconceptions,” supra note 10 (“[o]nly some of
the reported health conditions are side effects related to
vaccines. A certain number of VAERS reports of serious illnesses or
death do occur by chance alone among persons who have been recently
vaccinated”).

[137] “VAERS reports have many limitations
since they often lack important information, such as laboratory
results, used to establish a true association with the
vaccine.” Id.

[138] “In summary, scientists are not able to
identify a problem...based on VAERS reports alone without
scientific analysis of other factors and data.”
Id.

[141]See, e.g. , Gardiner Harris and Anahad
O’Connor, “On Autism’s Cause, It’s Parents
vs. Research,” New York Times, June 25, 2005, at
http://www.nytimes.com/2005/06/25/science/25autism.html (last
visited April 27, 2006) (reporting the ongoing tension between
parents of autistic children and the medical community over the use
of thimerosal in vaccines).

[142]See, e.g. , Center for Disease Control,
National Immunization Program publication, “Mercury and
Vaccines (Thimerosal),” at
http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/default.htm
(last visited April 27, 2006) (studies have failed to find any
association between exposure to thimerosal in vaccines and autism);
“On Autism’s Cause, It’s Parents vs.
Research,” supra (noting that the amount of ethyl
mercury in each childhood vaccine was once about the same as the
amount of methyl mercury, a more toxic compound, found in an
average tuna sandwich).

[150] “Thimerosal in Vaccines,”
supra note 139; see also “On Autism’s
Cause, It’s Parents vs. Research,”supra note 141
(“[b]y 2001, no vaccine routinely administered to children in
the United States had more than half a microgram of mercury –
about what is found in an infant’s daily supply of breast
milk”).

[153] Indeed, one recent study has suggested that
neurological disorders have decreased with the removal of
thimerosal from most vaccines. See David A. Geier and Mark R.
Geier, “Early Downward Trends in Neurodevelopmental Disorders
Following Removal of Thimerosal-Containing Vaccines,” 11 J.
Am. Physicians and Surgeons 8 (2006). This study should be taken
with a grain of salt, however, as the Geiers are widely known
thimerosal critics. Years before this study, Dr. Mark Geier called
thimerosal use in vaccines the world’s “greatest
catastrophe that’s ever happened, regardless of cause.”
“On Autism’s Cause, It’s Parents vs.
Research,” supra note 141. A witness in many vaccine
cases, a judge once ruled that he was “a professional witness
in areas for which he has no training, expertise and
experience.” Id. Scientists have criticized his prior
studies and even called his methods “voodoo science.”
Id.

[164]See, e.g. , “Six Common
Misconceptions,” supra note 10 (noting that many
anti-vaccine publications claim vaccines are unsafe on the basis of
sheer numbers of reports to VAERS without noting that many of them
may not represent actual vaccine side-effects).

[180] For example, she begs Rafe to consider his
family and what his decision could mean to them. She literally
appears to be on the verge of tears as he refuses.

[181] In utilizing the theoretical framework of
economic analysis, it is useful to keep in mind a few foundational
concepts. First, a policy or program (in this case mandatory
vaccination) is desirable if the overall benefit to society as a
whole outweighs the cost of the program, where benefits and costs
include both monetary and non-monetary factors. Second, individuals
making rational choices regarding vaccination will vaccinate when
the benefits of vaccination outweigh the risks or costs of
non-vaccination to the individual. This decision-making process can
be skewed by externalities, such as an unforeseeable decrease in
the effectiveness of a vaccine due to a reduction in vaccination by
others unknown to the individual at the time of the decision.

[188] As the CDC itself explains, “[e]ven one
serious adverse effect in a million doses of vaccine cannot be
justified if there is no benefit from the vaccination.”
“Six Common Misconceptions,” supra note 10.

[189] In Japan in the 1970s, for instance, pertussis
vaccination coverage fell from 80% to 20%, leading to an outbreak
in 1979 resulting in 13,000 cases and 41 deaths. “What Would
Happen If We Stopped Vaccinations?” supra note 91.

[190] Judge Richard Posner has suggested that this
difference between sexually transmitted diseases and air- and
water-borne diseases may imply a lesser imperative to eliminate
sexually transmitted diseases:

[T]he externality created by sexually transmitted
diseases is smaller than in the case of other contagious diseases.
Sexually transmitted disease is spread primarily by
voluntary contact, implying (to the economist) that a person
is compensated...for assuming the risk of contracting the disease.
Hence the number of cases of sexually transmitted diseases may be
closer to the optimum than in the usual air-borne or water-borne or
insect-borne epidemics.

Posner, Economic Analysis of Law 162. (6th Ed.
2003).

[191] Additionally, if vaccination rates are high,
these individuals may assume that those in society who have already
made the choice to vaccinate have performed a similar cost-benefit
analysis. These individuals choose to vaccinate based simply on
vaccination rates in the community. See John C. Hershey et
al., The Roles of Altruism, Free Riding, and Bandwagoning in
Vaccination Decisions , 59 Organizational Behavior and Human
Processes 177, 178 (1994).

[194]See id. at 178 (“[i]f a patient
believes vaccination is in his own best interests, then he has two
reasons to vaccinate. One is selfish, in that he will improve his
own well being. The other is altruistic, in that he can improve the
health prospects of those around him who might otherwise become
infected if he is not vaccinated himself”).

[195] The concept of herd immunity is discussed in
Part I. Note that “[i]n economic terms, herd immunity is a
positive externality of vaccination. Altruistic individuals who
recognize and value this externality may undergo vaccination partly
to help others in addition to themselves.” Id.See
also Berger, supra note 29 (“‘[h]erd
immunity’...is the concept that not everybody in a population
has to be immunised to protect everyone in that population. As long
as a sufficient number of children are immunised against each
disease for which there is a vaccine, protection against that
disease will be conferred on everybody”).

[196] The CDC has pointed to this as one of the two
most important reasons to vaccinate:

There is a small number of people who cannot be
vaccinated (because of severe allergies to vaccine components, for
example), and a small percentage of people don’t respond to
vaccines. These people are susceptible to disease, and their
only hope of protection is that people around them are
immune and cannot pass disease along to them. A successful
vaccination program, like a successful society, depends on the
cooperation of every individual to ensure the good of all.

“Six Common Misconceptions,” supra note
10.

[197] In economic terms, “[w]idening vaccine
use decreases each individual’s benefit from being
vaccinated, but leaves unchanged each individual’s risk from
the vaccination itself.” Hershey, supra note 191, at
178.

[200] Suppose, for sake of example, that a
vaccination program, if implemented, would save ten lives out of a
thousand that would otherwise have perished without the program.
Unfortunately, the vaccine will randomly cause death to five
persons out of a thousand. From an ex ante perspective, the
vaccination program should be implemented as it will save five
lives overall. Concerns or complaints from those five persons who
die (or their estates) represent ex post objections, and, though
unfortunate, should not affect evaluations of the soundness of the
program.

[201] This mathematical explanation is a slight
variation of that found at CDC, “Six Common
Misconceptions,” supra note __.

[202] Note that no vaccine is 100% effective, and
vaccination efficacy rates for most childhood vaccinations range
from 85 to 95%. Id. As stated in an earlier section, herd
immunity is relied upon to protect those who do not develop full
immunity from the vaccine.

[203] Given that these particular vaccines are
already on the schedule, I think it would be unwise to remove them
now. My analysis applies to comparable vaccines that may arise in
the future – vaccines for those communicable diseases that do
not pose relatively significant health risks. The definition of
such diseases, of course, would be a matter of debate. Vaccines for
noncommunicable diseases like ear infections would also fall within
this rubric.